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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035840
Receipt No. R000040710
Official scientific title of the study Advance Care Planning conducted by non-physician providers in Japanese primary care clinics : Mixed Method Research
Date of disclosure of the study information 2019/02/12
Last modified on 2019/02/12

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Basic information
Official scientific title of the study Advance Care Planning conducted by non-physician providers in Japanese primary care clinics : Mixed Method Research
Title of the study (Brief title) Advance Care Planning conducted by non-physician providers in Japanese primary care clinics
Region
Japan

Condition
Condition N/A
Classification by specialty
Medicine in general Geriatrics Nursing
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objectives of this evaluation is to establish an understanding of a practical way of ACP by non-physician providers in Japanese primary care clinics, including (1) Feasibility of ACP conducted by non-physician providers; and (2) Effective timing to conduct ACP systematically in busy workflow.
Basic objectives2 Others
Basic objectives -Others Feasibility
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes We will assess feasibility of ACP conducted by non-physician providers in Japanese primary care clinics by data from semi-structured interview and questionnaire.
Key secondary outcomes We will assess effective timing to conduct ACP systematically in busy workflow by data from semi-structured interview and questionnaire.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 We will train non-physician providers to be ACP facilitators. They will facilitate ACP for patients who are willing to discuss future medical care.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria We will include patients who are willing to discuss future medical care, such as patients at the time of getting an opinion letter for LTC insurance, at the time of discharge and at the time of transition to regularly home visit use.
Key exclusion criteria We will exclude patients who cannot express their thoughts.
Target sample size 30

Research contact person
Name of lead principal investigator Takahiro Mochizuki
Organization Japan Association for Development of Community Medicine (JADECOM)
Division name Institute of Community Medicine
Address 2-6-3 Hirakawacho Todoufukenkaikan15F, Chiyoda-ku, Tokyo, Japan
TEL 03-5212-9152
Email t-mochizuki@jadecom.or.jp

Public contact
Name of contact person Hiroyuki Horie
Organization Japan Association for Development of Community Medicine
Division name Institute of Community Medicine
Address 2-6-3 Hirakawacho Todoufukenkaikan15F, Chiyoda-ku, Tokyo, Japan
TEL 03-5212-9152
Homepage URL
Email hhorie@jadecom.jp

Sponsor
Institute Japan Association for Development of Community Medicine (JADECOM)
Institute
Department

Funding Source
Organization Japan Association for Development of Community Medicine (JADECOM)
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Oregon Health & Science University Department of Family Medicine
Name of secondary funder(s)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東通村診療所(青森県)、久瀬診療所(岐阜県)、西浅井地区診療所(滋賀県)、都祁診療所(奈良県)、

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 12 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 12 Month 06 Day
Anticipated trial start date
2019 Year 02 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2019 Year 02 Month 12 Day
Last modified on
2019 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040710

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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